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Reported Earlier, FDA Grants J&J Accelerated Approval For Rybrevant Faspro In Advanced Head And Neck Squamous Cell Carcinoma, Based On OrigAMI-4 Phase 1b/2 Trial Showing 42% Overall Response Rate

Benzinga·11/06/2026 06:01:59
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  • Accelerated approval based on data demonstrating clinically meaningful efficacy, including a 42 percent overall response rate (95 percent confidence interval, 32–52 percent)1
  • First advancement in the second-line treatment setting for recurrent or metastatic head and neck cancer in a decade, bringing a new subcutaneous option to patients with significant unmet need2-3 
  • Extending its well-established, dual-targeted benefit beyond lung cancer, RYBREVANT FASPRO™ targets both EGFR and MET pathways – two key drivers of tumor progression in head and neck cancer2